Reported Jul 15, 2015 · Terminated
The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Drive · Wayne, NJ · 07470
Is this the product you have?
- The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.
- Lot codes and dates
- Dual ArmPart #569710902 -
- Serial Numbers15664, 15672 thru 15673, 15738 thru 15739, 15791, 15803, 15818 thru 15819, 15822 thru 15823, 15830, 15834 thru 15835, 15881, 15889, 15981, 16016, 16019, 16058 thru 16064, 16066 thru 16067, 16120, 16284, 16286 thru 16287, 20076 thru 20077, 20142, 20151 thru 20152, 20155 thru 20157, 20193 thru 20194, 20216 thru 20220, 20249, 20256, 20258, 20263, 20270 thru 20271, 20277, 20292, 20300 thru 20301, 20304, 20337 thru 20338, 20342 thru 20343, 20350, 20464, 20504 thru 20506, 20508 thru 20511, 20523, 40002 thru 40003, 40014 thru 40015, 40031 thru 40032 and 40034. Part #567910904 -
- Serial Numbers13177, 13190 thru 13191, 13204, 13208, 13217, 13219 thru 13220, 13232, 13235 thru 13236, 13249, 13251 thru 13252, 13254 thru 13255, 13257 thru 13260, 13288, 20004, 20008, 20061, 20063, 20065 thru 20072, 20111 thru 20115, 20119 thru 20120, 20122, 40001 thru 40002 and 40011 thru 40013. Part #567910906 -
- Serial Numbers14509 thru 14510, 20014, 20085, 20091, 20097, 20101 thru 20104, 20114 thru 20115, 20231, 20246 and 40016 thru 40017. Part #567910913 -
- Serial Numbers12353 thru 12370, 12381, 12391 thru 12394, 20000 thru 20004, 20013, 20019 thru 20020, 20028 thru 20029, 20031, 20043 thru 20201, 20131 thru 20133, 20144 thru 20151, 20154 thru 20155, 20161, 40005, 40007 thru 40008 and 40018 thru 40020. Part #567910915 -
- Serial Numbers12646, 12648 thru 12652, 20026 thru 20027 and 40007. Part #567910923 -
- Serial Numbers12908, 20009 thru 20014 and 20022 thru 20023. Part #567910936 -
- Serial Numbers12150 thru 12152. Part #567910938 -
- Serial Numbers12067, 20007 thru 20011 and 40000. Part #567910957 -
- Serial Numbers
12295 thru 122961230412310123121234712356 thru 1236012409 thru 12410124162001120015 thru 2001620018200282003520041200632007040007 and 40009. Part #567910958 -
- Serial Numbers12254 thru 12263, 12273 thru 12275, 20010 thru 20011 and 40001. Part #567910961 -
- Serial Numbers
12386 thru 123891239312420 thru 1242112426 thru 124291247012476 thru 1247712481 thru 124831251412551 thru 1255312560200022002320045 thru 2004620048 thru 200512005320055 thru 200572006220065 thru 2006620068 thru 20071200732008120084 thru 20093201202012120123 thru 2012720138202022020620214 thru 2021520217 thru 2022120223 thru 202252022940006 thru 4000740023 and 40049. Part #567910964 -
- Serial Numbers12179 thru 12197, 12199, 12202 thru 12209, 20001 thru 20006, 20029, 20033 thru 20050, 20052 thru 20063, 20085 thru 20087, 40000 and 40002 thru 40003. Part #567910968 -
- Serial Numbers12054 thru 12060, 20004 thru 20008, 20012 thru 20018, 20023 thru 20028, 20044 and 40002 thru 40005. Part #567910970 -
- Serial Numbers12026 thru 12029, 12031 thru 12033, 12039 thru 12040 and 20005. Part #567910971 -
- Serial Numbers12178, 12194, 12196, 12198 thru 12201, 12204, 12207, 12210 thru 12211, 20000 thru 20002, 20005 thru 20008, 20019 thru 20020, 20022 thru 20025, 20032 thru 20040, 20043, 20048 thru 20050, 20056 thru 20061, 20063 thru 20067, 20071 thru 20073, 20079, 20083 thru 20085, 20090 thru 20104, 20119, 20125 thru 20129, 40007 thru 40010, 40012 and 40019 thru 40022. Part #567910986 -
- Serial Numbers10000, 10021 thru 10035, 20000 thru 20002 and 40000 thru 40004. Part #567910990 -
- Serial Numbers40026 thru 40028. Part #567910993 -
- Serial Number30005. Part #567912907 -
- Serial Numbers
100231002720006 and 40001. Part #567912908 -
- Serial Numbers10002, 10011, 20000 thru 20003 and 40000. Part #567912909 -
- Serial Numbers
100222001 thru 20002 and 20006. Part #567912911 -
- Serial Numbers
10001 thru 1000320000 and 40000. Part #567912912 -
- Serial Numbers20003 thru 20004, 20006 thru 20008 and 40000 thru 40006. Part #567912913 -
- Serial Numbers
1001220002 and 20004 thru 20005
- Triple ArmPart #567910917 -
- Serial Numbers20000 thru 20001, 20008 and 20010 thru 20019. Part #567910918 -
- Serial Numbers12664 and 20039 thru 20040. Part #567910965 -
- Serial Numbers
12102 thru 1210312105 thru 1210920006 thru 20007 and 20010 thru 20016
- Amount recalled
- 646 units
Where it was sold
- Nationwide
Why it was recalled
Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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